Pull out the popcorn, it's show time

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Happy Monday, readers.

We took the holiday to rest, play with fireworks (the legal kind, mostly) and now we’re back in action for this week’s dose of health care headlines. This week we take inspiration from the eponymous popcorn king, Orville Redenbacher. Born on July 16, nearly 110 years ago, Orville taught us that life and movies are better with popcorn. So, silence the cell phones and enjoy these previews and our feature.

The next big superbug: Last week, Novartis said it will fold its anti-microbial research center, signaling the latest major player to vacate the space. Despite emergence of new strains of antibiotic resistant super-bugs, many developers are leaving for fear that a breakthrough innovation may never pay off. Think about it: even if you succeed, antibiotics are often low-margin and used sparingly. Enter REVAMP, the Revaluing Anti-Microbial Products Act, a bi-partisan bill introduced in the House. If passed, REVAMP would reward developers of new, approved, antimicrobials by offering a year of protection on an existing medicine – which could represent BILLIONS in profits. So, unless we want to see a rerun of CONTAGION, we’re on board.

Blueprint negotiations go behind closed doors. Today is the deadline to submit comments on the President's Blueprint to Lower Drug Prices, but pharmacos are already feeling the PR and political heat. Between the Blueprint and transparency measures—like a recently implemented California law requiring advance notice of large price increases—Gilead and Novartis have opted not to take previously communicated price increases. And last week, Pfizer disclosed it would defer previously announced price increases to give the President an opportunity to work on his Blueprint. So, what’s really going on? Well, a hint may have come from HHS Secretary Alex Azar. The day before Pfizer froze its pricing, Sec. Azar told a closed door meeting of GOP representatives that hospitals should expect greater oversight of the 340B Drug Pricing Program. 340B currently requires manufacturers to provide drugs at heavily-reduced prices to hospitals that treat a disproportionate share of low-income patients. Azar proposed standardizing the discount to providers to 20% of the list price, a move that would ultimately benefit manufacturers. The plot thickens!

America’s toughest sheriff. No, not Joe Arpaio. It’s the DEA. The Department of Justice released a proposal that allows the government to control the supply of opioids is on the market. If the DEA, which already sets quotas for opioid manufacturing, deems that a specific drug is being diverted for misuse in large quantities, then it could issue even stricter limits for manufacturing.

Enjoy your popcorn and read on for the Main Attraction: The Week That Was.

►GROUNDHOG DAYThe star known for “breaking the Internet” with her derrière has taken her social media talents to the drug industry. On June 18th, Kim Kardashian posted an endorsement of a morning sickness treatment called Diclegis, but quickly took down the offending post for which the safety or ISI warning was absent. And, it turns out, it’s not Kardashian’s first time fudging the rules of pharma compliance. Loyal readers may recall that three years ago Kim posted on Twitter, Facebook and Instagram about Diclegis, and that post also lacked ISI and safety language. Regulators responded resoundingly at the time, slapping a warning letter and $500K fine on Duchesnay, the maker of Diclegis. But whether it was a fine-inducing faux pas or a proactive strategy remains unclear. The move paid off handsomely for Duchesnay: sales jumped more than 20% to nearly $41.7 million, according to data from IQVIA. The deal also paid Kardashian well – $500K for the posts – according to STAT. Image from the TodayShow.com►OUR TAKEIn its dealings with Kardashian, Duchesnay has now violated rules of disclosure on social media, not once but twice. And the move has seemingly benefitted the company with $41.7 million in sales vs. $500K in fines. But for marketers thinking it’s the Wild West for using uncompliant celebrities on social media, don’t get carried away. If you want to be a trusted brand, finding the right celebrity spokesperson and acting compliantly is critical. After Kardashian’s original posts for Diclegis several years ago, several doctors felt compelled to publish on the lack of efficacy behind the drug. And, if you need a reminder why it’s key to find the right celebrity, don’t forget Novo’s initial kerfuffle with Paula Deen!

►TRUE STORYIn the most obvious news of all time, a recent surveyfound that less than 50% of women make time to take care of routine health needs. Contrast that to the fact that 83% of women own health decisions for their families -- and you’ve got a real pickle of a problem. According to the survey, 80% of women feel they can’t delegate their family’s healthcare, but 90% describe themselves as having “moderate to high” stress. Alarmingly, 40% said they have anxiety or depression and most women say they don’t feel they can delegate the healthcare needs of their family.

►OUR TAKEIn a world where gender sensitivity is electrified, and many women (and men) are finding it hard to balance work, life and health, healthcare communicators need to be especially sensitive. Campaigns that aim to create disease awareness could ironically overwhelm the very audiences they seek to help. So what’s a healthcare communicator to do? We suggest taking a page from Lilly’s advertisement for Verzenio, a breast cancer drug. To develop the ad, the team met with hundreds of “women living with metastatic breast cancer in an effort to represent their voices as authentically and responsibly as possible.” Lilly went straight to the source to tell the truth about the daily realities of managing the disease.

►MISSION: IMPOSSIBLE On Wednesday, the FDA released six draft guidance documents on gene therapies—three of them disease specific (hemophilia, rare disease and retinal disorders), and three addressing manufacturing issues. In a statement, Commissioner Gottlieb says gene therapies represent: “one of the most promising opportunities for developing highly effective and even curative treatments for many vexing disorders. Some of these products are almost certainly going to change the contours of medical practice, and the destiny of patients with some debilitating diseases.” This news is also coming on the heels of CMS dropping its pilot outcomes-based contracting with Novartis’ CAR-T Kymriah.

►OUR TAKEThere’s ample excitement—and confusion surrounding the value of gene therapies. Their promise is staggering, and everyone from regulators to investors to the media is watching. But, the cost of this excitement is that all eyes are on value. Scott Gottlieb has said he expects the FDA to approve 40 new gene therapies by 2022. With expectations high, the question is: how will our system afford these potential cures…particularly when we don’t know if they’ll be curative forever? Word to the wise, gene therapy developers need to start working today with payers, policymakers and patient advocates to shape the reimbursement environment of the future. Whether that’s healthcoins (think bitcoins for health insurance) or other amortization schemes – the time is now to innovate insurance design if we hope to afford these miracle medicines.